When 2 Fed’s agendas are opposing each other and harming pts & no one seems to care

The chart below is the possible adverse effects to the human body if a pt’s pain is under/untreated.

I have listed below 5 different chronic health issues and the consequences to the pt if they are not properly treated. I have put in RED three of the chronic health issues that Medicare Part D & Medicare-C monitor how compliance the pt is in taking their medications for those chronic health issues.  They monitor to such a degree that if all the prescriber’s or pharmacy’s pts are determine to be out of compliance – I think that it is – on average – the pts are not taking 85% of their prescribed medications. That puts the STAR RATING of the prescriber & pharmacy at risk and that means that the reimbursement for caring for those pts will get “dinged”, and those practitioners will be getting “warning letters” from Medicare. So, the fact that Medicare is encouraging all practitioners to limit, reduce or eliminate adequate opioid therapy on chronic pain pts, is apparently counter productive in their “bean counting” if pts are taking their prescribed medications regularly and as prescribed. Since 1935 there has been a law that prohibits any Federal employee interfering with the practicing of medicine. A lawsuit against the 3 largest drug wholesalers by the vast majority of state AGs. Where they agreed to sell less controlled meds to community pharmacies. https://www.pharmaciststeve.com/pharma-prescribed-opioids-to-pts-with-valid-medical-necessity-0-022-pts-odd/kaiser/

The DEA, on a annual basis reduces the controlled med production quotas https://www.pharmaciststeve.com/proposed-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances/

Is it just me or is the DEA/DOJ doing their best efforts to prohibit chronic painers from getting their pain management therapy prescribed and/or pharmacies can’t get  pain medication(s) from their wholesaler and all of this direct/indirect denial of care could be impacting the pt’s co-morbidity issues that CMS is following how/if the pt’s co-morbidity issues are being properly managed. 

All of this push-pull with the DEA/DOJ & CMS involving how/if pts get appropriate care, could possible cause the pt to be falsely labeled as a PHARMACY SHOPPER and get more push back from practitioners and pharmacies because of the pt’s high Narxcare score, which they do not deserve, but could get punished all the same.

Below I outlined the adverse effects that pts may experience due to under/untreated pain, with other critical chronic health issues the pt is already dealing with or cause the pt to develop some other chronic health issues because of their under/untreated pain?

42 USC 1395: Prohibition against any Federal interference

https://uscode.house.gov/view.xhtml?req=(title:42%20section:1395%20edition:prelim)

From Title 42-THE PUBLIC HEALTH AND WELFARE CHAPTER 7-SOCIAL SECURITY SUBCHAPTER XVIII-HEALTH INSURANCE FOR AGED AND DISABLED

§1395. Prohibition against any Federal interference

Nothing in this sub chapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

(Aug. 14, 1935, ch. 531, title XVIII, §1801, as added Pub. L. 89–97, title I, §102(a), July 30, 1965, 79 Stat. 291 .)


Statutory Notes and Related Subsidiaries

Short Title

For short title of title I of Pub. L. 89–97, which enacted this subchapter as the “Health Insurance for the Aged Act”, see section 100 of Pub. L. 89–97, set out as a Short Title of 1965 Amendment note under section 1305 of this title.

Protecting and Improving Guaranteed Medicare Benefits

Pub. L. 111–148, title III, §3601, Mar. 23, 2010, 124 Stat. 538 , provided that:

“(a) Protecting Guaranteed Medicare Benefits.-Nothing in the provisions of, or amendments made by, this Act [see Short Title note set out under section 18001 of this title] shall result in a reduction of guaranteed benefits under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.].

“(b) Ensuring That Medicare Savings Benefit the Medicare Program and Medicare Beneficiaries.-Savings generated for the Medicare program under title XVIII of the Social Security Act under the provisions of, and amendments made by, this Act shall extend the solvency of the Medicare trust funds, reduce Medicare premiums and other cost-sharing for beneficiaries, and improve or expand guaranteed Medicare benefits and protect access to Medicare providers.”

 

 

 

 

 

 

 

 

 

 

 

 

 


 

If a patient’s high blood pressure (hypertension) is not properly controlled, it can lead to a wide range of serious and potentially life-threatening complications affecting multiple organ systems:

  • Cardiovascular system: Uncontrolled hypertension damages blood vessels, leading to heart attack, stroke, heart failure, angina, atherosclerosis (hardening and narrowing of the arteries), and aneurysms (which can rupture and be fatal)

  • Kidneys: High blood pressure can cause the blood vessels in the kidneys to narrow, weaken, or harden, leading to chronic kidney disease and potentially kidney failure

  • Brain: Hypertension increases the risk of stroke and can cause vascular dementia or other cognitive impairments due to reduced blood flow to the brain

  • Eyes: Damage to the small blood vessels in the eyes can result in retinopathy, leading to vision loss or even blindness

  • Sexual function: High blood pressure can cause erectile dysfunction in men and reduced libido or arousal issues in women

  • Metabolic syndrome: Uncontrolled hypertension can contribute to a cluster of conditions including increased waist size, high triglycerides, low HDL cholesterol, and high blood sugar, which increase the risk for diabetes, heart disease, and stroke

  • Other complications: These can include memory loss, fluid in the lungs, and, in severe cases, aortic dissection (a tear in the wall of the aorta)


Harms of Untreated Blood Sugar Abnormalities

When blood sugar is not properly managed—whether too high (hyperglycemia) or too low (hypoglycemia)—it can lead to serious, sometimes life-threatening complications. Below are the key risks associated with untreated blood sugar problems:

Untreated High Blood Sugar (Hyperglycemia)

Short-Term Complications:

  • Diabetic Ketoacidosis (DKA): A dangerous buildup of acids (ketones) in the blood, which can cause coma or death if not treated promptly.

  • Hyperosmolar Hyperglycemic State (HHS): Severe dehydration and very high blood sugar, leading to confusion, seizures, and coma

Long-Term Complications:

  • Heart and Blood Vessel Disease: Increased risk of heart attack, stroke, and poor circulation

  • Nerve Damage (Neuropathy): Tingling, pain, numbness, and loss of sensation, especially in the feet, which can lead to ulcers and amputations

  • Kidney Damage (Nephropathy): Can progress to kidney failure, requiring dialysis or transplantation

  • Eye Damage (Retinopathy): Can cause vision loss or blindness

  • Poor Wound Healing and Infections: Increased risk of skin, urinary tract, and other infections due to impaired immune function and circulation

  • Gum Disease and Tooth Loss: Higher risk of dental problems

  • Cognitive Impairment: Increased risk of memory loss and dementia

Long-Term Risks:

  • Brain Damage: Repeated or severe episodes can cause lasting cognitive impairment, especially in older adults

  • Increased Risk of Heart Disease: Episodes of severe hypoglycemia are linked to higher rates of cardiovascular events and mortality

  • Hypoglycemia Unawareness: Over time, the body may stop producing warning symptoms, increasing the risk of severe, unnoticed low blood sugar


If high cholesterol goes untreated, it can have significant and potentially life-threatening consequences for patients. The main risks stem from the gradual buildup of cholesterol-rich plaque in the arteries, a process known as atherosclerosis. This buildup narrows and hardens the arteries, restricting blood flow and increasing the risk of several serious conditions:

  • Coronary artery disease (CAD): Plaque accumulation in the arteries supplying the heart can lead to chest pain (angina), heart attacks, and heart failure. CAD is the leading cause of death in the U.S., and many people do not realize they have it until they experience symptoms or a cardiac event

  • Stroke: If plaque builds up in the arteries that supply the brain (such as the carotid arteries), it can reduce or block blood flow. A ruptured plaque can also trigger a blood clot, which may travel to the brain and cause a stroke. Strokes can lead to long-term disability or death

  • Peripheral artery disease (PAD): High cholesterol can cause narrowing of arteries in the limbs, particularly the legs, leading to pain, numbness, and, in severe cases, tissue damage or loss. PAD increases the risk of infections and poor wound healing

  • High blood pressure: Plaque buildup makes arteries less flexible and narrower, forcing the heart to work harder to pump blood, which can contribute to or worsen hypertension

  • Chronic kidney disease: Studies indicate that abnormal cholesterol levels double the risk of reduced kidney function over time. This can progress to chronic kidney disease, requiring dialysis or transplantation if not managed

  • Other complications: High cholesterol is often associated with diabetes, which further increases cardiovascular risk. It can also interact with other conditions (like thyroid disease or chronic inflammation) to worsen overall health outcomes

High cholesterol is typically asymptomatic—most people do not feel any different until a major event (like a heart attack or stroke) occurs

. This “silent” nature underscores the importance of regular screening and proactive management, especially since the risk increases with age and other factors such as genetics, diet, and lifestyle

In summary: Untreated high cholesterol significantly raises the risk of heart attack, stroke, peripheral artery disease, kidney disease, and death from cardiovascular causes. Early detection and treatment—through lifestyle changes and, if needed, medications—are essential to reduce these risks and improve long-term health outcomes


Low thyroid (T4) blood levels indicate hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone. This deficiency slows down many of the body’s metabolic processes and can cause a wide range of physical problems

The main physical problems associated with low T4 levels include:

  • Fatigue and weakness: People often feel unusually tired and lack energy, even after adequate rest

  • Weight gain: Metabolism slows, leading to unintentional weight gain despite no change or even a decrease in appetite

  • Cold intolerance: Increased sensitivity to cold temperatures is common due to reduced heat production

  • Dry skin and hair: Skin may become dry, rough, and pale; hair can become dry, brittle, and thin

  • Constipation: Slowed digestive processes can lead to persistent constipation

  • Muscle and joint pain: Muscle aches, stiffness, cramps, and joint pain or swelling are frequent complaints

  • Slow heart rate: The heart may beat more slowly, and in severe cases, hypothyroidism can contribute to heart failure or pericardial effusion (fluid around the heart)

  • Elevated cholesterol: Hypothyroidism can increase total and LDL cholesterol, raising the risk of heart disease

  • Menstrual and fertility issues: Women may experience heavier, irregular periods and fertility problems due to disrupted ovulation

  • Peripheral neuropathy: Long-term untreated hypothyroidism can damage peripheral nerves, causing numbness, tingling, or pain in the limbs

  • Mental health changes: Depression, slowed thinking, memory problems, and decreased interest in activities can occur

  • Goiter: The thyroid gland may enlarge as it attempts to compensate for low hormone production, sometimes causing visible swelling in the neck and difficulty swallowing

  • Myxedema: In severe, untreated cases, swelling of the skin and tissues (myxedema) can develop, and in extreme cases, lead to a life-threatening myxedema coma

In infants and children, untreated hypothyroidism can cause serious physical and mental developmental problems, but early diagnosis and treatment can prevent these outcomes

In summary: Low T4 levels slow down metabolism and can cause a range of symptoms affecting energy, weight, temperature regulation, skin, hair, heart, muscles, nerves, and reproductive health. If untreated, hypothyroidism can lead to significant complications, but it is generally treatable with hormone replacement therapy


Consequences of Long-Term Untreated SaO₂ ≤ 85%

When a patient’s arterial oxygen saturation (SaO₂) remains at or below 85% for an extended period without intervention, it leads to chronic hypoxemia. This condition can have severe and potentially irreversible effects on multiple organ systems.

Immediate and Short-Term Effects

  • Cognitive Impairment: Low oxygen levels can cause confusion, irritability, drowsiness, and visual changes. Severe hypoxemia can lead to loss of consciousness, seizures, or even coma.

  • Cardiorespiratory Symptoms: Patients may experience shortness of breath, rapid breathing, increased heart rate, and abnormal heart rhythms

  • Cyanosis: A bluish or grayish tint to the skin, especially when saturation drops below 75%, indicating dangerously low oxygen delivery to tissues

Long-Term Consequences

1. Neurological Damage

  • Brain Injury: Prolonged hypoxemia can result in irreversible brain damage, cognitive decline, and increased risk of stroke. Brain cells are highly sensitive to low oxygen and may die within minutes to hours of severe hypoxia

2. Cardiovascular Complications

  • Pulmonary Hypertension: Chronic low oxygen levels cause constriction of pulmonary arteries, leading to increased pressure (pulmonary hypertension)

  • Right-Sided Heart Failure (Cor Pulmonale): The right ventricle works harder to pump blood through the lungs, eventually leading to right-sided heart failure

  • Arrhythmias: Hypoxemia can trigger abnormal heart rhythms, increasing risk for sudden cardiac events

3. Hematological Changes

  • Secondary Polycythemia: The body compensates for low oxygen by producing more red blood cells, which thickens the blood and increases the risk of clotting and stroke

4. Multi-Organ Dysfunction

  • Organ Damage: Chronic hypoxia can irreversibly damage vital organs such as the brain, heart, kidneys, and liver, ultimately leading to organ failure

  • Reduced Exercise Tolerance & Quality of Life: Muscle dysfunction, fatigue, and reduced stamina are common, limiting daily activities

5. Increased Mortality

  • Higher Risk of Death: Studies show that persistently low oxygen saturation is independently associated with increased all-cause mortality, especially from pulmonary and cardiovascular diseases

Summary Table: Major Consequences

System Affected Consequence
Brain Cognitive decline, seizures, coma, brain death
Heart & Lungs Pulmonary hypertension, right heart failure, arrhythmias
Blood Secondary polycythemia, increased clot risk
Organs (multi-system) Irreversible organ damage, failure
General Increased mortality, reduced quality of life

Key Points

  • SaO₂ ≤ 85% is a medical emergency and requires prompt intervention.

  • Untreated chronic hypoxemia leads to progressive, often irreversible, multi-organ damage and significantly shortens life expectancy

  • Early recognition and treatment are critical to prevent these severe complications.

DOJ Subpoenas Doctors Over Youth Gender Care

DOJ Subpoenas Doctors Over Youth Gender Care

https://www.medpagetoday.com/washington-watch/washington-watch/116458

The U.S. Department of Justice (DOJ) announced that it had sent more than 20 subpoenas to doctors and clinics “involved in performing transgender medical procedures on children.”

Though additional details on the subpoenas and their recipients were not immediately available, the department said investigations include healthcare fraud and false statements.

“Medical professionals and organizations that mutilated children in the service of a warped ideology will be held accountable by this Department of Justice,” Attorney General Pamela Bondi said in a statement.

The issue also came up in a Wednesday workshop held by the Federal Trade Commission (FTC) on “unfair or deceptive trade practices” in gender-affirming care for youth.

Speaking at the event, Chad Mizelle, chief of staff at the DOJ, noted that “there’s a basic principle of law, you cannot deceive consumers.”

“You cannot lie to them to get them to buy your products, use your services,” Mizelle said. “You cannot commit fraud. This is true in providing medical services, but also more generally. There’s no doubt in my mind, based not only on what we’ve heard here today, but just looking around with our own eyes, that the industry that is formed around providing gender-affirming care and transitioning services for children has perpetuated one of the greatest frauds on the American public.”

“One of the most important tasks of government is to prevent this fraud from continuing and to remedy the consequences of this fraud,” he added.

The subpoenas are just the latest in a string of actions taken by the Trump administration regarding gender-affirming care for youth.

In January, President Donald Trump issued an executive order entitled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.”

And in May, a 409-page report from HHS urged therapy for transgender youth rather than broader gender-affirming care, questioning standards of treatment issued by the World Professional Association for Transgender Health (WPATH). The Associated Press noted at the time that the report was likely to be used to support the federal government’s “abrupt shift in how to care for a subset of the population that has become a political lightning rod.” Medical experts sharply criticized the report as inaccurate.

Also in May, CMS announced that it had sent a letter to certain hospitals “performing pediatric sex trait modification procedures outlining urgent concerns with both the quality standards adherence and profits related to these harmful procedures.”

In June, the FBI issued a public plea on X: “As the Attorney General has made clear, we will protect our children and hold accountable those who mutilate them under the guise of gender-affirming care.” It then asked for reports of any hospitals, clinics, or practitioners performing these surgical procedures on children.

Additionally, the HHS Office for Civil Rights began an investigation into a major health system in Michigan regarding allegations that a healthcare provider there fired a medical professional for “exercising her federally protected rights of conscience” after requesting religious accommodation from certain employment practices. These included “requiring use of patient pronouns that do not align with the patient’s sex,” and “assisting in certain sex trait modification procedures.”

And earlier this month, the Wall Street Journal reported that the Trump administration was weighing whether to cut funding to hospitals that provide gender-affirming care for youth.

In a statement to MedPage Today, WPATH and its U.S. arm, USPATH, said the FTC workshop “sends a discouraging and unfortunate message – that the lives and very existence of transgender and gender-diverse youth are somehow up for debate. Let us be perfectly clear: they are not.”

“Transgender and gender diverse youth are human beings deserving of dignity, respect, and the freedom to access healthcare that can improve their lives and well-being in consultation with their parents and doctors,” the statement said. It continued that the workshop was a way for the federal government to “platform misinformation, further sow division, and weaponize patient-doctor relationships to pursue a purely political agenda.”

Judge Orders CVS’ Omnicare Unit to Pay $949 Million Over Invalid Prescriptions

Judge Orders CVS’ Omnicare Unit to Pay $949 Million Over Invalid Prescriptions

https://gvwire.com/2025/07/08/judge-orders-cvs-omnicare-unit-to-pay-949-million-over-invalid-prescriptions/

  • The pharmacy giant was accused of filing more than 3.3 million false claims for reimbursement by the U.S. government.
  • The fraudulent claims surfaced as a result of a whistleblower lawsuit filed by a former Omnicare pharmacist.
  • Omnicare improperly billed Medicare, Medicaid, and Tricare for prescriptions for tens of thousands of patients in assisted-living and other long-term care facilities

NEW YORK — A federal judge ordered CVS Health’s Omnicare unit to pay $948.8 million in penalties and damages, in a whistleblower lawsuit claiming it fraudulently billed the U.S. government for invalid drug prescriptions.

In a Monday evening order, U.S. District Judge Colleen McMahon in Manhattan imposed a $542-million penalty for filing 3,342,032 false claims between 2010 and 2018.

McMahon also awarded $406.8 million of damages, representing three times the $135.6 million that a jury awarded on April 29.

The tripling was required under the federal False Claims Act, which lets whistleblowers sue on behalf of the federal government and share in recoveries.

CVS plans to appeal the judgment. The Woonsocket, Rhode Island-based drugstore chain and pharmacy benefits manager bought Omnicare in 2015. Omnicare has asked McMahon to throw out the case or grant a new trial.

“This lawsuit centered on a highly technical prescription dispensing recordkeeping issue that was allowed by law in many states,” CVS said in a statement on Tuesday. “There was no claim in this case that any patient paid for a medication they shouldn’t have or that any patient was harmed.”

The lawsuit was filed in 2015 by Uri Bassan, a former Omnicare pharmacist in Albuquerque, New Mexico, and joined by the federal government in 2019.

Lawsuits Alleged Improper Billing

They said Omnicare improperly billed Medicare, Medicaid, and Tricare, which serves military personnel, for prescriptions for tens of thousands of patients in assisted-living facilities, group homes for people with special needs, and other long-term care facilities.

Omnicare allegedly assigned new prescription numbers without necessary paperwork and pharmacist approvals, after the original prescriptions expired or ran out of refills.

McMahon rejected CVS’ argument that a $948.8-million award violated the U.S. Constitution’s prohibition against excessive fines under the Eighth Amendment.

“This was a very big fraud on the government, one that lasted over almost a decade, and one that Omnicare was aware of but avoided taking steps to correct,” the judge wrote.

McMahon found CVS jointly liable with Omnicare for $164.8 million of the penalties, after jurors found it failed to stop Omnicare from submitting 30% of the false claims after buying that company. CVS itself did not submit any claims.

The case is U.S. ex rel Bassan v. Omnicare Inc, U.S. District Court, Southern District of New York, No. 15-04179.

 

Google – Gemini AI – is out after your data on your Android cell phone

The message below is going around the web and apparently Google has decided to let their AI program Gemini to have access to all the data on a Android cell phone, unless you do specific things to stop it from doing this. Remember your data is part of the next “gold rush” and worth a lot money to Goggle and whoever Google sells your data to

 

Switch to Dry-Powder Inhaler Worsened COPD, Asthma Patient Outcomes

Switch to Dry-Powder Inhaler Worsened COPD, Asthma Patient Outcomes

Veterans Affairs formulary change acted as a “natural experiment” for the study

https://www.medpagetoday.com/pulmonology/smokingcopd/116412

Key Takeaways

  • Switching from a metered-dose to a dry-powder inhaler after a formulary change increased emergency department visits and hospitalizations in people with COPD or asthma.
  • The absolute changes in risk were small.
  • The findings suggested potential harm from the switch, with the medication, the device, and other factors potentially contributing.

Shifting from a metered-dose inhaler to a dry-powder inhaler for chronic obstructive pulmonary disease (COPD) and asthma in one healthcare system formulary led to increased healthcare utilization, a study showed, suggesting potential harm.

Patients who were switched from budesonide-formoterol metered-dose inhaler (Symbicort) to fluticasone-salmeterol dry-powder inhaler (Wixela Inhub) had 5% more all-cause emergency department visits and more hospitalizations as well — increases of 8% overall, 10% respiratory-related, and 24% pneumonia-related — as compared with pre-change rates in a within-person, self-controlled case series.

The absolute differences in hospitalizations in a matched observational cohort of those who switched and those who didn’t were 0.49 percentage points more for switchers overall, 0.41 percentage points more for respiratory causes, and 0.12 percentage points more for pneumonia over 180 days.

These findings suggested “potential harm and the need to reevaluate this policy change,” researchers led by Alexander Rabin, MD, of the Veterans Affairs Ann Arbor Healthcare System in Michigan, reported in JAMA Internal Medicine

Dry-powder inhalers eliminate the hydrofluorocarbon propellants used in metered-dose inhalers, which could reduce healthcare-related greenhouse gas emissions

However, dry-powder inhalers put different demands on patients “Metered-dose inhalers deliver medication to the lungs independent of inspiratory effort but require patients to coordinate actuation with inhalation, whereas dry-powder inhalers rely on rapid, deep inhalation to minimize oropharyngeal deposition, which may be difficult for patients with diminished lung function,” the researchers explained.

Using the “natural experiment” of the Veterans Health Administration’s formulary change in July 2021, the investigators followed outcomes for all 260,268 patients on combination inhaler therapy for treatment of COPD and asthma both before and after the formulary change.

The primary analysis was a self-controlled case series of the 260,268 patients already on budesonide-formoterol before the formulary change who were switched to fluticasone-salmeterol. Their median age was 71 years, 91% were male, and 69% had COPD, while 32% had asthma.

Findings were “robust” across sensitivity and subgroup analyses, the team reported.

Of these patients who switched inhalers and experienced the adverse outcomes of interest, the findings showed that during treatment with fluticasone-salmeterol dry-powder inhaler therapy there were:

  • 10% fewer albuterol fills (incidence rate ratio [IRR] 0.90, 95% CI 0.90-0.91)
  • 2% more prednisone fills (IRR 1.02, 95% CI 1.01-1.03)
  • 5% more all-cause emergency department visits (IRR 1.05, 95% CI 1.04-1.06)
  • 8% more all-cause hospitalizations (IRR 1.08, 95% CI 1.06-1.09)
  • 10% increased respiratory-related hospitalizations (IRR 1.10, 95% CI 1.07-1.14)
  • 24% more pneumonia-specific hospitalizations (IRR 1.24, 95% CI 1.17-1.31)

To eliminate the risk of temporal confounding with a self-controlled analysis and to be able to generate absolute risk differences, the researchers also completed a cohort study with 167,331 patients who switched to fluticasone-salmeterol dry-powder inhaler therapy matched with 91,226 patients who continued receiving other inhaler therapy.

No difference was seen in 90- or 180-day mortality nor in albuterol or prednisone fills between groups.

Limitations of the study included inability to directly measure inhaler use, the largely older male population, and the focus on relatively short-term outcomes.

“A key question raised by our study is whether the increased incidence of adverse outcomes among patients who switched to the dry-powder fluticasone-salmeterol inhaler was associated with the medication, the device, or other factors. The answer likely involves all three factors,” the investigators suggested.

In terms of the medication, industry-sponsored head-to-head comparisons of the two inhaler combinations have shown similar clinical efficacy, but “other studies indicate that fluticasone is associated with a higher pneumonia risk than budesonide, likely due to its more sustained systemic and local immunosuppressive effects,” Rabin and colleagues wrote.

A relative unfamiliarity with dry-powder inhalers might have decreased tolerance, worsening disease control, while “older patients with COPD may also have struggled to generate sufficient inspiratory force for effective dry-powder drug delivery,” the group added. Forced device switching can decrease medication adherence too, with errors in inhalation technique worsening clinical outcomes.

“Implementation strategies likely play a role in lessening the impact associated with inhaler formulary changes: how transitions are implemented may be as important as the choice of drug or device,” the researchers concluded. “Structured inhaler education and clear patient and health care professional communication during formulary changes are essential to minimize interruptions in care. Regular reassessment of inhalation technique and peak flow monitoring may also improve dry-powder drug delivery among patients who switch to this device class.”

Let’s get to the CHASE – why your Rx COST SO DAMN MUCH!

I have always contended that the average Rx price went up in direct proportion of the percentage of the Rx market that the PBM’s controlled
Look at the chart below, as the percentage of generics increased, which should have showed the average Rx price would have been lower, but the percentage of the Rx market place that the PBM controlled. The average Rx price went up.

How Insurance/PBM industry use PAs to pad their bottom line

 

 

 

 

 

 

Clinical Trial Sheds Light on Daily CBD Use and Liver Enzymes

Clinical Trial Sheds Light on Daily CBD Use and Liver Enzymes

https://www.medpagetoday.com/gastroenterology/generalhepatology/116386

Key Takeaways

  • Daily CBD use at typical consumer doses led to significant liver enzyme elevations in healthy adults.
  • About 6% of CBD users had liver enzymes over three times the normal upper limit.
  • CBD use is common in the U.S. and should be part of routine medical screening in certain patients.

Some trial participants had peak levels ten times higher than normal upper limit

Daily use of cannabidiol (CBD) at doses commonly reported by consumers was associated with potentially dangerous increases in liver enzymes, a randomized clinical trial found.

Among 201 healthy adult participants followed for 28 days, eight (5.6%) of those randomized to CBD had liver enzyme levels greater than three times the upper limit of normal (ULN) compared with none in the placebo group, said a team of FDA scientists led by Jeffry Florian, PhD, of the FDA’s Center for Drug Evaluation and Research in Silver Spring, Maryland.

Five individuals (3.3%) experienced peak aminotransferase levels greater than five times the ULN, and two (1.3%) had aminotransferase levels greater than 10 times the ULN, with the highest more than 18 times higher. These seven participants met criteria for drug-induced liver injury, Florian’s team reported online in JAMA Internal Medicine

Eosinophilia was also observed in seven of the eight individuals with elevated liver enzymes. However, no participants experienced jaundice or clinical symptoms related to impaired liver function, and liver enzymes normalized within 1 to 2 weeks of discontinuing CBD, the researchers said.

“This clinical trial is part of the FDA efforts to understand the safety of CBD products and inform discussions about safeguards and oversight to manage and minimize risks with CBD products. These findings may have important implications for consumers who may otherwise be unaware of potential safety risks,” Florian and colleagues wrote.

“Given the growing popularity of unregulated CBD-containing products in the market and the ability of CBD to cause liver enzyme level elevations, inclusion of CBD use as part of routine medical screening could be considered, particularly in patients with existing liver conditions or those taking medications metabolized by the liver,” they added. “For patients presenting with elevated liver enzymes, CBD use could be considered in the differential diagnosis.”

In an accompanying editorial, Nathan Stall, MD, PhD, of the University of Toronto, and Kenneth Covinsky, MD, MPH, of the University of California San Francisco, noted that data from the 2022 National Survey on Drug Use and Health indicated that more than 20% of U.S. adults reported using CBD in the past year. “Given the high use and increasing access to CBD without a prescription, the study by Florian et al raises several important concerns,” they wrote.

The results “underscore that clinicians should be aware of CBD-associated hepatoxic effects and screen patients with elevated liver enzyme levels for CBD use. Finally, regulators should balance the free market proliferation of CBD with the need for increased public awareness and clinical vigilance,” Stall and Covinsky said.

The randomized, double-blinded, placebo-controlled trial was conducted from January to August 2024 using per protocol analysis. It included healthy adults recruited from a clinical pharmacology unit. Participants were randomized to CBD 5 mg/kg/d (2.5 mg/kg/d twice daily), or placebo for 28 days. Laboratory assessments were done weekly. The primary endpoint was the percentage of participants with an alanine aminotransferase or aspartate aminotransferase level elevation greater than three times the ULN during the study.

Limitations included that the study enrolled healthy participants between 18-55 years of age who were not taking other medications and who had no comorbidities that could have increased their susceptibility to hepatic enzyme level elevations, so impacts on populations outside these conditions were not captured. In addition, the study’s short duration could not determine potential longer-term health effects. Because dosing was discontinued when elevated liver enzymes were observed, it is not known whether they would have resolved on their own or escalated further.

Finally, the researchers noted, the CBD dosing in the study was within the range of reported consumer use, but it was on the higher end and administered twice daily. “While many consumers report taking unregulated CBD more than once daily, most consume it less frequently. In addition, given the reports of inaccurate labeling of some over-the-counter CBD products, it is possible that individuals self-dosing CBD are consuming different doses than expected,” they said.

 

The DOJ/DEA AGENDA doesn’t seem to align with the FACTS & TRUTH

The Decade of Pain Law expired in 2009-2010 and the political majority of  Congress had FLIPPED and it was not renewed.

Between 1985 and 2025 our population has increased 43%. Between 2010 & 2025 the MME/capita reduced 54 %

The number of opioid Rxs filled peaked 2010-2012.

Between 2010 & 2023 number of filled opioid Rxs dropped 69%

The graphic directly below is from ~ 2014.

 

 

 

 

 

If you look at the last graphic on this page, notice that OD/poisoning was flat to lower from 2012 on Rx opioids, but OD/poisoning from synthetic opioids (illegal Fentanyl, etc) went from abt 5,000 to 70,000 by 2021. while at abt the same time frame filled Rx opioids dropped 64%. 

Maybe someone should asked the DOJ/DEA how they come to the conclusion that Rx opioids is behind all the increased OD/poisoning over abt 14 yr period, when the number of filled Rx opioids dropped down by nearly 2/3 in the same/similar time frame.  Maybe the DOJ/DEA’s agenda is based on outdated facts and just working on their fabricated opinions.

 

 

 

 

 

 

IMAGINE THIS: Louisiana filed several lawsuits accusing pharmaceutical giant CVS of abusing customer information

Louisiana files lawsuits alleging pharmaceutical giant CVS deceived customers in text messages

https://apnews.com/article/louisiana-cvs-lawsuit-text-message-liz-murrill-landry-38cfcac6ff3bed3ce6358ca7bab34214

NEW ORLEANS (AP) — Louisiana filed several lawsuits accusing pharmaceutical giant CVS of abusing customer information and using its dominant market position to drive up drug costs and unfairly undermine independent pharmacies, the state’s attorney general said Tuesday.

Attorney General Liz Murrill began investigating CVS after the company sent out mass text messages to thousands of residents on June 11 to lobby against legislation that took aim at its business structure. The texts warned that medication costs could go up and all CVS pharmacies in the state would close.

The lawsuits, which were filed Monday in central Louisiana’s St. Landry Parish, seek “injunctive relief, civil penalties and restitution,” Murrill said.

CVS “abused customers’ sensitive information to push a political message,” Republican Gov. Jeff Landry said Tuesday at a press conference.

He noted CVS had lobbied his wife over text via the same messaging chain normally used to notify her about picking up a prescription drug or other healthcare-related matters.

One lawsuit argues that the text message lobbying constituted “unfair or deceptive acts” in violation of state trade law. Two Louisiana-based law firms have filed a separate class action lawsuit against CVS over the text messages.

CVS has denied any wrongdoing.

“Our communication with CVS customers, patients and members of the community was consistent with the law,” CVS said in an emailed statement. “We believe it was important for people to know about a potential disruption to where they get their medicine.”

Two other lawsuits allege that CVS artificially inflates prices for consumers and independent pharmacies.

CVS serves as a pharmacy benefit manager — essentially an intermediary that buys medication from manufacturers and distributes drugs to pharmacies.

CVS and the mail-order pharmacy Express Scripts dominate the market by processing about eight out of every 10 prescription drug claims, according to the Federal Trade Commission, which warned in a 2024 report that this allows for “inflating drug costs and squeezing Main Street pharmacies.”

Because CVS also owns a vast network of retail pharmacies — including 119 in Louisiana — it sets the terms for how prescription drugs are sold to customers there.

The proposed law that sparked the text messages from CVS had sought to ban pharmacy benefit managers like CVS from owning drug stores. The law failed to pass, but Landry has stated he will seek to revive it.

In the state’s litigation, Murrill alleges that CVS business structure and practices allow the company to “manipulate prices, restrict competition and channel profits internally.”

One lawsuit accuses CVS of “systematically under-reimbursing independent Louisiana pharmacies to the point of economic hardship, while routing patients to CVS-owned facilities.” The lawsuit alleges that CVS imposes “unethical, unscrupulous, and exorbitantly high fees on independent pharmacies.”

CVS said that it should not have to pay higher rates for “less efficient pharmacies” and that this would lead to “higher costs for consumers.”

“Importantly, CVS Pharmacy remains the lowest cost pharmacy and a critical partner in lowering prescription drug costs for Louisianans,” the company said.

Another lawsuit argues that CVS uses its market control to exclude lower-cost drugs for “high-rebate, high-price brand drugs” and other practices that “distort the drug market” and “drive up costs for the state’s public health programs and its citizens.”

CVS said that its business structure allows for “better access, affordability, and advocacy for those we serve.” The company said that removing CVS pharmacies from Louisiana would increase costs to the state by more than $4.6 million.

Landry said he would seek new legislation targeting CVS if existing laws were insufficient to win in court.

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